[Federal Register Volume 65, Number 17 (Wednesday, January 26, 2000)]
[Rules and Regulations]
[Pages 4112-4121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1785]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 803 and 804
[Docket No. 98N-0170]
Medical Device Reporting: Manufacturer Reporting, Importer
Reporting, User Facility Reporting, Distributor Reporting
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations governing reporting by manufacturers, importers,
distributors and health care (user) facilities of adverse events
related to medical devices. Amendments are being made to implement
revisions to the Federal Food, Drug, and Cosmetic Act (the act) as
amended by the Food and Drug Administration Modernization Act of 1997
(FDAMA).
EFFECTIVE DATE: March 27, 2000.
FOR FURTHER INFORMATION CONTACT: Susan E. Bounds, Center for Devices
and Radiological Health (HFZ-500), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-594-2735.
SUPPLEMENTARY INFORMATION:
I. General
In the Federal Register of September 14, 1984 (49 FR 36326), FDA
issued medical device reporting regulations for manufacturers and
importers under the act and the Medical Device Amendments of 1976 (the
1976 amendments) (Public Law 94-295). To correct weaknesses noted in
the 1976 amendments, and to better protect the public health by
increasing reports of device-related adverse events, Congress enacted
the Safe Medical Devices Act of 1990 (the SMDA) (Public Law 101-629),
which required medical device user facilities and distributors to
report certain device-related adverse events.
Distributor reporting requirements became effective on May 28,
1992, following the November 26, 1991 (56 FR 60024), the publication of
those provisions in a tentative final rule. In the Federal Register of
September 1, 1993 (58 FR 46514), FDA published a notice announcing that
the proposed distributor reporting regulations had become final by
operation of law and were now codified in part 804 (21 CFR part 804).
[[Page 4113]]
On June 16, 1992, the President signed into law the Medical Device
Amendments of 1992 (the 1992 amendments) (Public Law 102-112) amending
certain provisions of section 519 of the act (21 U.S.C. 360i) relating
to reporting of adverse device events. Among other things, the 1992
amendments amended section 519 of the act to modify the requirements
for manufacturer and importer reporting. Under the regulations issued
under the SMDA and the 1992 amendments, importers are required to
report as manufacturers if they are engaged in manufacturing activities
or to report as distributors if they are engaged solely in distribution
activities.
On November 21, 1997, the President signed FDAMA (Public Law 105-
115) into law. FDAMA made several changes regarding the reporting of
adverse experiences related to devices. On May 12, 1998, FDA published
a proposed rule (63 FR 26129) (hereinafter referred to as the May 1998
proposal) and a direct final rule (63 FR 26069) (hereinafter referred
to as the May 1998 direct final rule) to implement the amendments to
the Medical Device Reporting (MDR) provisions. FDA received at least
one significant adverse comment on the direct final rule. Accordingly,
consistent with FDA's procedures on direct final rulemaking, FDA is
withdrawing the May 1998 direct final rule and is addressing the
comments in this final rule based upon the May 1998 proposal.
The May 1998 proposal was intended to amend the medical device
reporting requirements to implement the following changes made by
FDAMA:
1. Section 213(a) of FDAMA revised section 519(a) of the act to
eliminate distributors as an entity required to report adverse device
events. Importers are still required to report under section 519(a) of
the act.
2. Section 213(a) of FDAMA also amended section 519(a) of the act
to clarify that existing requirements for distributors to keep records
concerning adverse device events and make them available to FDA upon
request continue to apply.
3. Section 213(a)(2) of FDAMA revoked section 519(d) of the act,
which required manufacturers, importers, and distributors to submit to
FDA an annual certification concerning the number of reports filed
under section 519(a) in the preceding year. As a result, certification
requirements are eliminated.
4. Section 213(c)(1)(A) of FDAMA revised section 519(b)(1)(C) of
the act to require that device user facilities submit an annual rather
than a semiannual summary of their reports to FDA.
5. Section 213(c)(1)(B) of FDAMA eliminated section 519(b)(2)(C) of
the act. This section had required FDA to disclose, upon request, the
identity of a device user facility making a report under section 519(b)
of the act if the identity of the device user facility was included in
a report required to be submitted by a manufacturer, distributor, or
importer. As a result of this change by FDAMA, FDA now may disclose the
identity of a device user facility only: in connection with an action
concerning a failure to report or false or fraudulent reporting; in a
communication to the manufacturer of the device; or to the employees of
the Department of Health and Human Services, the Department of Justice,
and duly authorized committees and subcommittees of Congress.
6. Section 422 of FDAMA states that FDA's regulatory authority
under the act, relating to tobacco products, tobacco ingredients, and
tobacco additives shall be exercised under the act as in effect on the
day before the date of enactment of FDAMA. The proposal stated that,
under this rule of construction, the reporting requirements for
manufacturers and distributors (including distributors who are
importers) of cigarettes or smokeless tobacco would remain unchanged.
Furthermore, along with the substantive changes to the MDR
provisions required by FDAMA, the agency proposed certain
nonsubstantive changes to the organization of the provisions contained
in parts 803 (21 CFR part 803) and 804. These organizational changes
did not affect any reporting burdens; rather, the changes were made for
the sake of clarity and consistency within the CFR.
II. Summary of Comments
The agency received nine comments submitted by medical device
manufacturers, importers, distributors, and trade associations.
1. Four comments stated that the agency did not follow Congress'
direction that FDA consider changing the distributor recordkeeping
requirements. The Congressional Conference Committee (the Conference
Committee) recommended that FDA consider limiting the length of time
that distributors are required to retain records to a period of 6 years
(the current requirement is a minimum of 2 years, or the expected life
of the product). The Conference Committee also recommended that FDA
consider providing for electronic retention of records.
The agency disagrees that it did not properly follow Congress'
direction or intent. The Conference Committee recommended that the
agency consider changes to the distributor recordkeeping requirements.
However, FDAMA contained no provisions that required any specific
changes to the requirements.
The agency carefully considered the recommendations of the
conference committee. The agency determined that the protection of the
public health would not be adequately served if distributor
recordkeeping was limited to a period of 6 years. Under the new quality
system regulations contained in part 820 (21 CFR part 820),
manufacturers (including initial distributors of foreign manufacturers)
must retain records for a period equal to the design and expected life
of the device (but no less than 2 years). The agency believes it is
appropriate to require distributors to retain records for the same time
period. This is especially important because distributors are no longer
required to report any adverse event information to the agency, and the
agency's primary access to the distributor complaint information is
through its periodic inspection and examination of the distributor
records.
FDA also considered electronic retention of distributor records.
Prior to FDAMA and the proposed rule, the agency had not prohibited the
electronic retention of records, nor did it intend to prohibit
electronic recordkeeping based upon the proposal. When the distributor
recordkeeping requirements were shifted from part 804 to part 803, the
language remained largely unchanged. However, in order to avoid further
confusion regarding electronic retention of records, the agency is
modifying proposed Sec. 803.18(d)(1) to clarify that distributor
records may be either written or electronic.
2. Three comments stated that in describing distributor
recordkeeping, reference to the quality system regulations,
specifically Sec. 820.198 (Complaint files), is inappropriate because
Sec. 820.198 applies only to manufacturers.
The agency agrees with this comment in part. The section being
revoked (804.35) references Sec. 820.198 because many of the
recordkeeping requirements in Sec. 820.198 would apply to all
distributors. However, for the sake of clarity, the agency is revising
Sec. 803.18(d) to remove the reference to Sec. 820.198, and is
substituting language to identify the relevant requirements from
Sec. 820.198 that apply to distributors who are not importers.
3. Two comments suggested that the requirement that importers
submit
[[Page 4114]]
adverse event reports within 10 days be changed to allow 30 days for
reporting.
The agency agrees and is modifying the regulation accordingly.
Prior to the SMDA, importers were subject to the same reporting
timeframes as manufacturers under the 1984 MDR regulation. Consistent
with the requirements of the SMDA, the 10-day reporting requirement was
imposed on distributors and, because part 804 defined distributors to
include importers, the 10-day reporting requirement was imposed on
importers as well. Under FDAMA, distributors are no longer required to
submit adverse event reports, but the reporting requirements continue
to apply to importers. Because importers are subject to many of the
same requirements as manufacturers under the new quality system
regulations contained in part 820, the agency will allow importers the
same 30 days it provides manufacturers to gather information and submit
reports.
4. One comment stated that the fields to be filled out on FDA Form
3500A (MEDWATCH reporting form) should be specifically identified for
importers. The comment also requested clarification regarding whether
the agency's definition of ``importer'' for the purpose of MDR includes
firms who sell directly to the ultimate user.
The agency agrees that the fields to be filled out by importers on
FDA Form 3500A should be specified within the regulation. Because the
requirements and burdens would not be affected by revising the style
and format of Sec. 803.43, the agency is modifying the section to be
consistent with Secs. 803.32 and 803.52, which describe the information
to be submitted on the MEDWATCH form. Furthermore, proposed Sec. 803.43
was inadvertently misnumbered. For the sake of consistency in
numbering, the final rule will renumber this section as Sec. 803.42.
The agency notes that, because ``distributors'' had previously been
defined to include ``importers,'' FDA Form 3500A does not specifically
address importer information and does not use the term ``importers.''
However, block F of the MEDWATCH form is identified for use by device
user facilities and distributors. An importer should continue to
complete blocks A, B, D, E, and F until the form is revised to remove
references to ``distributor'' and replace them with ``importer.''
The agency clarifies that firms who purchase products from a
foreign manufacturer and sell directly to the ultimate user are
considered retailers and not importers under part 803 and are not
required to report.
5. One comment stated that distributor reporting is important for
the protection of the public health. The comment recommended, as an
alternative to distributor reporting, a modification to the medical
device labeling requirements to require that manufacturer contact
information be included in the labeling for all devices in order to
ensure proper adverse event reporting.
The agency agrees that consumers are likely to contact medical
device distributors with their device complaints. Without distributor
reporting, it is possible that the agency will not receive information
regarding some complaints. However, under FDAMA, the agency no longer
has the authority to require distributor reporting.
Although distributors are no longer under an obligation to report
adverse device events, the agency continues to encourage distributors
to provide manufacturers with adverse event information so that
consumer complaints may be appropriately investigated and reported.
The alternative suggestion that manufacturer contact information be
included in device labeling would be likely to increase the amount of
information the manufacturer and the agency receives from the consumer.
However, implementing this type of change to the medical device
labeling regulation is beyond the scope of this rule. The agency is
currently reviewing its medical device labeling regulation and
considering certain modifications. The question of manufacturer contact
information appearing on device labeling will be considered as part of
that regulatory effort.
6. One comment stated that the agency erroneously interpreted
section 422 of FDAMA, regarding the regulation of tobacco products,
tobacco ingredients, or tobacco additives. The comment stated that
section 422 simply provides that nothing in FDAMA shall affect the
question of whether or not FDA has authority to regulate such products.
The comment suggests that, if FDA has the authority to regulate such
products, they should be regulated in the same manner as other medical
devices.
The agency disagrees with this comment. Section 422 of FDAMA states
that ``Nothing in this Act or the amendments made by this Act shall be
construed to affect the question of whether the Secretary of Health and
Human Services has any authority to regulate any tobacco product,
tobacco ingredient, or tobacco additive.'' Although this language may
suggest that FDAMA is simply silent regarding the agency's authority to
regulate tobacco, section 422 goes on to state that ``Such authority,
if any, shall be exercised under the Federal Food, Drug, and Cosmetic
Act as in effect on the day before the date of the enactment of this
act.'' Beyond the question of whether the agency has authority to
regulate tobacco, this language directs the agency as to how it should
exercise any such authority once pending litigation is resolved.
Under section 422 of FDAMA, therefore, Congress neither affirms nor
denies the agency's authority to regulate tobacco, but it does direct
the agency to continue regulating tobacco as it had been doing prior to
FDAMA (if authority to regulate tobacco exists). Prior to FDAMA,
distributor reporting and manufacturer and distributor certification
were required under the act. If the agency were to exercise its
authority under the act ``as in effect on the day before the date of
the enactment of [FDAMA],'' distributor reporting and manufacturer and
distributor certification requirements would continue to apply to
manufacturers and distributors of cigarettes and smokeless tobacco
products.
However, while the agency disagrees with the comment's
interpretation of section 422 of FDAMA, FDA finds persuasive the
comment's arguments that tobacco manufacturers and distributors should
be exempt from the requirement of annual certification of MDR's and
that distributors should be exempt from MDR reporting requirements
under the residual authority of the act. The agency has authority under
section 519(c) of the act to exempt, by regulation, any class of
persons from the medical device reporting requirements upon a finding
that such reporting by that class is not necessary to ``assure that a
device is not adulterated or misbranded or * * * otherwise to assure
its safety and effectiveness'' (21 U.S.C. 360i(c)). The agency finds
that the statutory criteria for exemption are met because reasonable
assurances will be provided by the remaining medical device reporting
requirements, that is, reporting and recordkeeping required by
manufacturers and importers and recordkeeping required by distributors.
7. On its own initiative, FDA has revised Sec. 803.22(b)(2) to make
clear that importers who receive reportable information about a device
not imported by them need not submit a report to FDA but, instead, must
forward the information to FDA along with a cover letter explaining
that they do not import the device in question.
[[Page 4115]]
8. On its own initiative, FDA has determined that it is not
necessary for importers to submit supplemental reports under
Sec. 803.56 as proposed. Instead, FDA will require importers to submit
additional information only when requested by FDA under Sec. 803.15. No
change to Sec. 803.15 is necessary.
9. Also on its own initiative, FDA has made some nonsubstantive
changes to the definitions in Sec. 803.3 in order to integrate the
requirements for importer reporting into part 803.
III. Environmental Impact
The agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IV. Analysis of Impacts
FDA has examined the impacts of this final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of
1995 (Public Law 104-4). Executive Order 12866 directs agencies to
assess all costs and benefits of available regulatory alternatives and,
when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). The agency believes that this final rule is consistent
with the regulatory philosophy and principles identified in the
Executive Order. The Office of Management and Budget (OMB) has
determined that this final rule is a significant regulatory action
subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The rule codifies the elimination of reporting by
distributors, continues reporting by importers as they have been doing
to date with an extension of the time for reporting, increases
protection from disclosure of the identity of device user facilities
that have submitted reports, reduces summary reporting by device user
facilities from semiannual to annual, eliminates annual certification
for manufacturers and distributors (including importers) of medical
devices, and makes other nonsubstantive changes. The agency certifies
that this final rule will not have a significant negative economic
impact on a substantial number of small entities. This final rule also
does not trigger the requirement for a written statement under section
202(a) of the Unfunded Mandates Reform Act because it does not impose a
mandate that results in an expenditure of $100 million or more by
State, local, or tribal governments in the aggregate, or by the private
sector, in any one year.
V. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title,
description, and respondent description of the information collection
provisions are shown below with an estimate of the annual reporting
burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
Title: Reporting and recordkeeping requirements for manufacturers,
importers, user facilities, and distributors of medical devices under
the FDA Modernization Act (FDAMA)--General Requirements.
Description: FDAMA contained provisions that affect medical device
reporting in a variety of ways. Section 213 of FDAMA eliminated the
reporting requirements for medical device distributors (but not for
importers), as well as the certification requirements for medical
device manufacturers and distributors. This section of FDAMA also
modified the summary reporting requirements for user facilities to
require annual, rather than semiannual, reporting, and increased
confidentiality of user facility identities.
This final rule amends FDA's regulations in part 803 and revokes
part 804 to reflect the changes to medical device reporting made by
FDAMA. The final rule has also been amended to implement the exemptions
for manufacturers and distributors of cigarettes and smokeless tobacco
products discussed below.
In accordance with 5 CFR 1320.8(d), on May 12, 1998, requests for
public comment were published in the Federal Register (see 63 FR 26069
and 63 FR 26129). Several comments were received in response to the
proposed rule and are discussed in detail previously in this final
rule.
Four comments objected that FDA did not follow the congressional
recommendation in the conference report on FDAMA that FDA limit the
time that distributors be required to keep records to a maximum of 6
years. The direct final rule required that distributors keep records
for 2 years or the expected life of the device, whichever is greater.
FDA carefully considered the recommendations of the conference
committee. The agency determined that the protection of the public
health would not be adequately served if distributor recordkeeping was
limited to a period of 6 years. Under the new quality system
regulations contained in part 820, manufacturers (including initial
distributors of foreign manufacturers) must retain records for a period
equal to the design and expected life of the device (but no less than 2
years). The agency believes it is appropriate to require distributors
to retain records for the same time period. This is especially
important because distributors are no longer required to report any
adverse event information to the agency, and the agency's primary
access to the distributor complaint information is its periodic
inspection and examination of the distributor records.
FDA considered electronic retention of distributor records. Prior
to FDAMA and the May 1998 proposal, the agency had not prohibited the
electronic retention of records, nor did it intend to prohibit
electronic recordkeeping based upon the May 1998 proposal. When the
distributor recordkeeping requirements were shifted from part 804 to
part 803, the language remained largely unchanged. However, in order to
avoid further confusion regarding electronic retention of records, the
agency is modifying proposed Sec. 803.18(d)(1) to clarify that
distributor records may be either written or electronic.
Three comments stated that it is inappropriate to refer to the
quality systems regulations (Sec. 820.198) in describing distributor
recordkeeping because Sec. 820.198 does not apply to distributors.
FDA agrees and has revised Sec. 803.18(d) accordingly to remove the
reference to Sec. 820.198. FDA is substituting language to identify the
relevant requirements from Sec. 820.198 that apply to distributors who
are not importers. FDA notes, however, that Sec. 820.198 does apply to
importers of devices.
Two comments suggested that the reporting timeframe for importers
should be changed to 30 days from 10 days.
FDA agrees with these comments and has revised the final rule.
Previously,
[[Page 4116]]
importers were included in part 804 with the reporting requirements for
distributors. Because distributors are no longer required to report,
part 804 is eliminated and importers are included in part 803 with
manufacturers. The 30-day timeframe is consistent with the timeframe
for manufacturers.
One comment suggested that the form for reporting adverse events
(FDA Form 3500A) should be revised to refer specifically to importers.
Another comment asked for clarification as to whether a person who
sells directly to the ultimate user may be considered an ``importer''.
The agency agrees that the fields to be filled out by importers on
FDA Form 3500A should be specified within the regulation. Because the
requirements and burdens would not be affected by revising the style
and format of Sec. 803.43, the agency is modifying the section to be
consistent with Secs. 803.32 and 803.52, which describe the information
to be submitted on the MEDWATCH form. Furthermore, proposed Sec. 803.43
was inadvertently misnumbered. For the sake of consistancy in
numbering, the final rule will renumber this section as Sec. 803.42.
The agency notes that, because ``distributors'' had previously been
defined to include ``importers,'' FDA Form 3500A does not specifically
address importer information and does not use the term, ``importers.''
However, block F of the MEDWATCH form is identified for use by device
user facilities and distributors. An importer should continue to
complete blocks A, B, D, E, and F until the form is revised to remove
references to ``distributor'' and replace them with ``importer.'' The
agency clarifies that firms who purchase products from a foreign
manufacturer and sell directly to the ultimate user are considered
retailers and not importers under part 803 and are not required to
report.
One comment suggested that distributor reporting is important for
the protection of the public health and recommended that, as an
alternative to distributor reporting, FDA should require manufacturer
contact information on the labeling to assure proper adverse event
reporting.
The agency agrees that consumers are likely to contact medical
device distributors with their device complaints. Without distributor
reporting, it is possible that the agency will not receive information
regarding some complaints. However, under FDAMA, the agency no longer
has the authority to require distributor reporting. Although FDA cannot
require distributor reporting, FDA encourages distributors to report
adverse event information to manufacturers so that they may investigate
and report it as appropriate. The suggestion that FDA require
manufacturer contact information on the labeling is beyond the scope of
this rule and FDA will consider it separately.
One comment objected that FDA incorrectly interpreted section 422
of FDAMA regarding the regulation of tobacco products, tobacco
ingredients and tobacco additives. The comment stated that section 422
only means that nothing in FDAMA shall affect whether FDA has the
authority to regulate tobacco products. The comment further said that
section 422 of FDAMA does not mean, as FDA believes, that the
requirements, such as MDR reporting, for manufacturers and distributors
of tobacco products are unchanged by FDAMA.
The agency disagrees with this comment. Section 422 of FDAMA states
that ``Nothing in this Act or the amendments made by this Act shall be
construed to affect the question of whether the Secretary of Health and
Human Services has any authority to regulate any tobacco product,
tobacco ingredient, or tobacco additive.'' Although this language may
suggest that FDAMA is simply silent regarding the agency's authority to
regulate tobacco, section 422 of FDAMA goes on to state that ``Such
authority, if any, shall be exercised under the Federal Food, Drug, and
Cosmetic Act as in effect on the day before the date of the enactment
of this act.'' Beyond the question of whether the agency has authority
to regulate tobacco, this language directs the agency as to how it
should exercise such authority once pending litigation is resolved.
Under section 422 of FDAMA, therefore, Congress neither affirms nor
denies the agency's authority to regulate tobacco, but it does direct
the agency to continue regulating tobacco as it had been doing prior to
FDAMA (if authority to regulate tobacco exists). Prior to FDAMA,
distributor reporting and manufacturer and distributor certification
were required under the act. If the agency were to exercise its
authority under the act ``as in effect on the day before the date of
the enactment of [FDAMA],'' distributor reporting and manufacturer and
distributor certification requirements would continue to apply to
manufacturers and distributors of cigarettes and smokeless tobacco
products.
However, while the agency disagrees with the comment's
interpretation of section 422 of FDAMA, FDA finds persuasive the
comment's arguments that tobacco manufacturers should be exempt from
the requirement of annual certification of MDR's and that distributors
should be exempt from MDR reporting requirements under the residual
authority of the act. The agency has authority under section 519(c) of
the act to exempt, by regulation, any person from the medical device
reporting requirements upon a finding that such reporting is not
necessary to ``assure that a device is not adulterated or misbranded or
* * * otherwise to assure its safety and effectiveness'' (21 U.S.C.
360i(c)). The agency finds that the statutory criteria for exemption
are met in light of the fact that Congress has repealed the
requirements for manufacturer and distributor annual certification and
distributor reporting. A reasonable assurance of the safety and
effectiveness of tobacco products will be provided by the remaining
medical device reporting requirements, that is, reporting and
recordkeeping required of manufacturers and importers and recordkeeping
required of distributors.
FDA estimates the burden for this collection of information as
follows:
[[Page 4117]]
Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section/FDA Form No. of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
803.15 50 1 50 4 200
803.19 150 1 150 3 450
803.22(b)(2) 100 1 100 .25 25
803.33 (FDA Form 3419) 1,800 1 1,800 1 1,800
803.40 195 1 195 3 585
803.55 (FDA Form 3417) 1,000 20 20,000 1.1 22,000
Total 25,060
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records recordkeeper
----------------------------------------------------------------------------------------------------------------
803.17 2,000 1 2,000 3.3 6,600
803.18 39,764 1 39,764 1.5 59,646
Total 66,246
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burdens under this direct final rule are explained as follows:
A. Reporting Requirements
Prior to the program change reflected in this rule, distributors
(including importers) were required to submit supplemental information
under Sec. 804.32. Distributors (who are not importers) are no longer
required to submit MDR reports (including supplemental reports), and
FDA has determined that it will not be necessary for importers to
submit supplemental information except when FDA requests additional
information under Sec. 803.15. FDA has revised the final rule
accordingly. Section 803.15 provides that FDA may request a reporter to
submit additional or clarifying information concerning an MDR report
when FDA determines that additional information is necessary for the
protection of the public health. The burden estimate for this section
includes only the burden for importers.
Prior to the program change reflected in this rule, Sec. 803.19
allowed manufacturers or user facilities to request an exemption or
variance from the reporting requirements. The agency had estimated that
it would receive approximately 100 such requests annually. Distributors
(including importers) were able to request an exemption or variance
from the reporting requirements under Sec. 804.33. Under this rule,
Sec. 803.19 is modified to transfer the exemption provisions for
importers of medical devices from Sec. 804.33 to Sec. 803.19.
Furthermore, distributors (who are not importers) of medical devices
are no longer required to submit MDR reports under this rule. The
estimated burden for Sec. 803.19 is further adjusted to reflect the
agency's actual experience with this type of submission.
Prior to the program change reflected in this rule,
Sec. 803.22(b)(2) provided that, if a manufacturer erroneously receives
information about an adverse event concerning a device that they had
not manufactured, the manufacturer must submit the report to FDA along
with a cover letter explaining that the device in question was not
manufactured by that firm. This final rule amends Sec. 803.22(b)(2) to
apply the same requirement to importers. The requirements of
Sec. 803.22(b)(2) were not previously reviewed by OMB under the PRA.
Thus, the estimated burden reflects FDA's experience with this
provision with regard to manufacturers and includes the estimated
burden for both manufacturers and importers.
Prior to the program change reflected in this rule, Sec. 803.33
required medical device user facilities to submit summary reports
semiannually. Under this rule, user facilities are required to submit
summary reports annually, thereby significantly decreasing the
reporting burden on user facilities. The estimated burden for this
section is also adjusted to reflect the agency's actual experience with
this type of submission. FDA Form 3419 is being revised to reflect this
change.
Under this rule the reporting requirement for importers of medical
devices previously codified under Sec. 804.25 is being transferred to
Sec. 803.40. The estimated burden for importer reporting is based upon
the agency's actual experience with this type of submission. Section
803.40 requires importers to submit reports within 30 days after
learning of the reportable event rather than 10 days as provided in
Sec. 804.25; this change does not affect the burden.
This rule does not amend Sec. 803.55 but FDA is seeking approval
for FDA Form 3417 on which baseline reports are to be submitted. The
agency's estimate is based on FDA's actual experience with this type of
submission.
Prior to the program change reflected in this rule, Sec. 803.57
required medical device manufacturers to annually certify as to the
number of reports submitted during the previous year, or that no such
reports had been submitted. Distributors (including importers) were
required to certify under Sec. 804.30. As stated above, FDA is also
exempting manufacturers and distributors of cigarettes and smokeless
tobacco products from the requirement of annual certification.
Therefore, under this rule, Secs. 803.57 and 804.30 are being
eliminated.
Because distributors, including distributors of cigarettes and
smokeless tobacco products, will no longer be required to report, the
final rule also removes Secs. 804.25 (Reports by distributors), 804.32
(Supplemental information), and 804.33 (Alternative reporting
requirements).
B. Recordkeeping Requirements
Prior to the program change reflected in this rule, Sec. 803.17
required manufacturers and user facilities to establish written
procedures for employee education, complaint
[[Page 4118]]
processing, and documentation of information related to MDR's. Under
this rule, the requirements for establishing written MDR procedures for
importers of medical devices have been transferred to Sec. 803.17. The
agency believes that the majority of manufacturers, user facilities,
and importers have already established written procedures to document
complaints and information related to MDR reporting as part of their
internal quality control system. The agency has estimated that no more
than 2,000 such entities would be required to establish new procedures,
or revise existing procedures, in order to comply with this provision.
For those entities, a one-time burden of 10 hours, annualized over a
period of 5 years, is estimated for establishing written MDR
procedures. The remainder of manufacturers, user facilities, and
importers not required to revise their written procedures to comply
with this provision are excluded from the burden because the
recordkeeping activities needed to comply with this provision are
considered ``usual and customary'' under 5 CFR 1320.3(b)(2).
Prior to the program change reflected in this rule, Sec. 803.18
required manufacturers and user facilities to establish and maintain
MDR event files. Distributors (including importers) were required to
establish and maintain MDR event files under Sec. 804.35. Under this
rule, Sec. 803.18 is modified to transfer the recordkeeping
requirements for importers and other distributors of medical devices
including cigarettes and smokeless tobacco products from Sec. 804.35
and Sec. 804.35 is removed. As discussed above, this recordkeeping may
be done in an electronic format.
Under the proposed rule, distributors of cigarettes and smokeless
tobacco products would have been required to establish written internal
procedures for evaluating and reporting events. Because distributors of
cigarettes and smokeless tobacco products will not be required to
report under the final rule, Sec. 804.34 is deleted from the final
rule.
The information collections of this final rule have been submitted
to OMB for review. Prior to the effective date of the final rule, FDA
will publish a notice in the Federal Register announcing OMB's decision
to approve, modify, or disapprove the information collection provisions
of this final rule. An agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number.
List of Subjects in 21 CFR Parts 803 and 804
Imports, Medical devices, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR
chapter I is amended as follows:
PART 803--MEDICAL DEVICE REPORTING
1. The authority citation for 21 CFR part 803 continues to read as
follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
2. Section 803.1 is amended by revising paragraph (a) to read as
follows:
Sec. 803.1 Scope.
(a) This part establishes requirements for medical device
reporting. Under this part, device user facilities, importers, and
manufacturers, as defined in Sec. 803.3, must report deaths and serious
injuries to which a device has or may have caused or contributed, must
establish and maintain adverse event files, and must submit to FDA
specified followup and summary reports. Medical device distributors, as
defined in Sec. 803.3, are also required to maintain records of
incidents (files). Furthermore, manufacturers and importers are also
required to report certain device malfunctions. These reports will
assist FDA in protecting the public health by helping to ensure that
devices are not adulterated or misbranded and are safe and effective
for their intended use.
* * * * *
3. Section 803.3 is amended by redesignating paragraphs (m) through
(ee) as paragraphs (n) through (ff), respectively; by revising
paragraph (c), the first sentence of paragraph (f), newly redesignated
paragraphs (p) introductory text and (p)(1), paragraph (r) introductory
text and paragraph (r)(2), and by adding paragraphs (g) and (m) to read
as follows:
Sec. 803.3 Definitions.
* * * * *
(c) Become aware means that an employee of the entity required to
report has acquired information reasonably suggesting a reportable
adverse event has occurred.
(1) Device user facilities are considered to have ``become aware''
when medical personnel, as defined in paragraph (s) of this section,
who are employed by or otherwise formally affiliated with the facility,
acquire such information about a reportable event.
(2) Manufacturers are considered to have become aware of an event
when:
(i) Any employee becomes aware of a reportable event that is
required to be reported within 30 days or that is required to be
reported within 5 days under a written request from FDA under
Sec. 803.53(b); and
(ii) Any employee, who is a person with management or supervisory
responsibilities over persons with regulatory, scientific, or technical
responsibilities, or a person whose duties relate to the collection and
reporting of adverse events, becomes aware that a reportable MDR event
or events, from any information, including any trend analysis,
necessitate remedial action to prevent an unreasonable risk of
substantial harm to the public health.
(3) Importers are considered to have become aware of an event when
any employee becomes aware of a reportable event that is required to be
reported by an importer within 30 days.
* * * * *
(f) Device user facility means a hospital, ambulatory surgical
facility, nursing home, outpatient diagnostic facility, or outpatient
treatment facility as defined in paragraphs (l), (b), (t), (u), and
(v), respectively, of this section, which is not a ``physician's
office,'' as defined in paragraph (w) of this section. * * *
(g) Distributor means, for the purposes of this part, any person
(other than the manufacturer or importer) who furthers the marketing of
a device from the original place of manufacture to the person who makes
final delivery or sale to the ultimate user, but who does not repackage
or otherwise change the container, wrapper or labeling of the device or
device package. One who repackages or otherwise changes the container,
wrapper, or labeling, is a manufacturer under paragraph (o) of this
section.
* * * * *
(m) Importer means, for the purposes of this part, any person who
imports a device into the United States and who furthers the marketing
of a device from the original place of manufacture to the person who
makes final delivery or sale to the ultimate user, but who does not
repackage or otherwise change the container, wrapper, or labeling of
the device or device package. One who repackages or otherwise changes
the container, wrapper, or labeling, is a manufacturer under paragraph
(o) of this section.
* * * * *
(p) Manufacturer or importer report number means the number that
uniquely identifies each individual adverse event report submitted by a
[[Page 4119]]
manufacturer or importer. This number consists of three parts as
follows:
(1) The FDA registration number for the manufacturing site of the
reported device, or the registration number for the importer. (If the
manufacturing site or the importer does not have a registration number,
FDA will assign a temporary MDR reporting number until the site is
officially registered. The manufacturer or importer will be informed of
the temporary number.);
* * * * *
(r) MDR reportable event (or reportable event) means:
(1) * * *
(2) An event about which manufacturers or importers have received
or become aware of information that reasonably suggests that one of
their marketed devices:
(i) May have caused or contributed to a death or serious injury; or
(ii) Has malfunctioned and that the device or a similar device
marketed by the manufacturer or importer would be likely to cause a
death or serious injury if the malfunction were to recur.
* * * * *
Sec. 803.9 [Amended]
4. Section 803.9 Public availability of reports is amended by
adding ``or'' after the semicolon at the end of paragraph (c)(2), by
removing paragraph (c)(3), and by redesignating paragraph (c)(4) as
paragraph (c)(3).
5. Section 803.10 is amended by revising the heading and paragraph
(a)(2), and by adding paragraph (b) to read as follows:
Sec. 803.10 General description of reports required from user
facilities, importers, and manufacturers.
(a) * * *
(2) User facilities must submit annual reports as described in
Sec. 803.33.
(b) Importers must submit MDR reports of individual adverse events
within 30 days after the importer becomes aware of an MDR reportable
event as described in Sec. 803.3. Importers must submit reports of
device-related deaths or serious injuries to FDA and to the
manufacturer and reports of malfunctions to the manufacturer.
* * * * *
Sec. 803.11 [Amended]
6. Section 803.11 Obtaining the forms is amended in the first
sentence by adding the word ``, importers,'' after the phrase ``User
facilities''.
7. Section 803.12 is amended by revising paragraph (b) to read as
follows:
Sec. 803.12 Where to submit reports.
* * * * *
(b) Each report and its envelope shall be specifically identified,
e.g., ``User Facility Report,'' ``Annual Report,'' ``Importer Report,''
``Manufacturer Report,'' ``5-Day Report,'' ``Baseline Report,'' etc.
* * * * *
Sec. 803.17 [Amended]
8. Section 803.17 Written MDR procedures is amended in the
introductory text by adding the word ``, importers,'' after the phrase
``User facilities''.
9. Section 803.18 is amended by revising the heading, the first
sentence of paragraphs (a) and (b)(1) introductory text, paragraphs
(b)(1)(ii) and (b)(2), and the second sentence of paragraph (c), and by
adding paragraph (d) to read as follows:
Sec. 803.18 Files and distributor records.
(a) User facilities, importers, and manufacturers shall establish
and maintain MDR event files. * * *
(b)(1) For purposes of this part, ``MDR event files'' are written
or electronic files maintained by user facilities, importers, and
manufacturers. * * *
* * * * *
(ii) Copies of all MDR forms, as required by this part, and other
information related to the event that was submitted to FDA and other
entities (e.g., an importer, distributor, or manufacturer).
(2) User facilities, importers, and manufacturers shall permit any
authorized FDA employee during all reasonable times to access, to copy,
and to verify the records required by this part.
(c) * * * Manufacturers and importers shall retain an MDR event
file relating to an adverse event for a period of 2 years from the date
of the event or a period of time equivalent to the expected life of the
device, whichever is greater. * * *
(d)(1) A device distributor shall establish and maintain device
complaint records containing any incident information, including any
written, electronic, or oral communication, either received by or
generated by the firm, that alleges deficiencies related to the
identity (e.g., labeling), quality, durability, reliability, safety,
effectiveness, or performance of a device. Information regarding the
evaluation of the allegations, if any, shall also be maintained in the
incident record. Device incident records shall be prominently
identified as such and shall be filed by device, and may be maintained
in written or electronic form. Files maintained in electronic form must
be backed up.
(2) A device distributor shall retain copies of the records
required to be maintained under this section for a period of 2 years
from the date of inclusion of the record in the file or for a period of
time equivalent to the expected life of the device, whichever is
greater, even if the distributor has ceased to distribute the device
that is the subject of the record.
(3) A device distributor shall maintain the device complaint files
established under this section at the distributor's principal business
establishment. A distributor that is also a manufacturer may maintain
the file at the same location as the manufacturer maintains its
complaint file under Secs. 820.180 and 820.198 of this chapter. A
device distributor shall permit any authorized FDA employee, during all
reasonable times, to have access to, and to copy and verify, the
records required by this part.
* * * * *
Sec. 803.19 [Amended]
10. Section 803.19 Exemptions, variances, and alternative reporting
requirements is amended by adding in paragraphs (b) and (c) the word
``, importers,'' before the phrase ``or user facility'', and by adding
in paragraph (c) a comma after the word ``variance''.
11. Section 803.20 is amended by revising the last sentence of the
introductory text of paragraph (a), paragraph (a)(1), and the first
sentence of paragraph (a)(2), and by adding paragraph (b)(2) to read as
follows:
Sec. 803.20 How to report.
(a) * * * The form has sections that must be completed by all
reporters and other sections that must be completed only by the user
facility, importer, or manufacturer.
(1) The front of FDA Form 3500A is to be filled out by all
reporters. The front of the form requests information regarding the
patient, the event, the device, and the ``initial reporter'' (i.e., the
first person or entity that submitted the information to the user
facility, manufacturer, or importer).
(2) The back part of the form contains sections to be completed by
user facilities, importers, and manufacturers. * * *
(b) * * *
(2) Importers are required to submit death and serious injury
reports to FDA and the device manufacturer and submit malfunction
reports to the manufacturer only:
(i) Within 30 days of becoming aware of information that reasonably
suggests that a device has or may have caused or contributed to a death
or serious injury.
[[Page 4120]]
(ii) Within 30 days of receiving information that a device marketed
by the importer has malfunctioned and that such a device or a similar
device marketed by the importer would be likely to cause or contribute
to a death or serious injury if the malfunction were to recur.
* * * * *
Sec. 803.22 [Amended]
12. Section 803.22 When not to file is amended by adding in
paragraphs (a) and (b)(1) the word ``, importer,'' after the word
``facility'' and in paragraph (b)(2) by adding the phrase ``or
importer'' after the word ``manufacturer'' each time it appears and by
adding the phrase ``or imported'' after the word ``manufactured'' each
time it appears.
Sec. 803.33 [Amended]
13. Section 803.33 Semiannual reports is amended by revising the
heading to read ``Annual reports''; in the introductory text of
paragraph (a) by removing the phrase ``(for reports made July through
December) and by July 1 (for reports made January through June)''; in
the introductory text of paragraph (a) and paragraphs (a)(5), (a)(7)
introductory text, and (c) by removing the word ``semiannual'' wherever
it appears and adding in its place the word ``annual''; in paragraph
(a)(1) by revising the reference ``Sec. 803.3(dd)'' to
``Sec. 803.3(ee)''; in paragraph (a)(2) by removing the phrase ``and
period, e.g., January through June or July through December'' and in
paragraph (a)(7)(vi) by adding the word ``importer,'' after the word
``distributor,''.
14. Subpart D, consisting of Secs. 803.40 and 803.42, is added to
read as follows:
Subpart D--Importer Reporting Requirements
Sec.
803.40 Individual adverse event reporting requirements; importers.
803.42 Individual adverse event report data elements.
Sec. 803.40 Individual adverse event reporting requirements;
importers.
(a) An importer shall submit to FDA a report, and a copy of such
report to the manufacturer, containing the information required by
Sec. 803.42 on FDA form 3500A as soon as practicable, but not later
than 30 days after the importer receives or otherwise becomes aware of
information from any source, including user facilities, individuals, or
medical or scientific literature, whether published or unpublished,
that reasonably suggests that one of its marketed devices may have
caused or contributed to a death or serious injury.
(b) An importer shall submit to the manufacturer a report
containing information required by Sec. 803.42 on FDA form 3500A, as
soon as practicable, but not later than 30 days after the importer
receives or otherwise becomes aware of information from any source,
including user facilities, individuals, or through the importer's own
research, testing, evaluation, servicing, or maintenance of one of its
devices, that one of the devices marketed by the importer has
malfunctioned and that such device or a similar device marketed by the
importer would be likely to cause or contribute to a death or serious
injury if the malfunction were to recur.
Sec. 803.42 Individual adverse event report data elements.
Individual medical device importer reports shall contain the
following information, in so far as the information is known or should
be known to the importer, as described in Sec. 803.40, which
corresponds to the format of FDA Form 3500A:
(a) Patient information (Block A) shall contain the following:
(1) Patient name or other identifier;
(2) Patient age at the time of event, or date of birth;
(3) Patient gender; and
(4) Patient weight.
(b) Adverse event or product problem (Block B) shall contain the
following:
(1) Adverse event or product problem;
(2) Outcomes attributed to the adverse event, that is:
(i) Death;
(ii) Life threatening injury or illness;
(iii) Disability resulting in permanent impairment of a body
function or permanent damage to a body structure; or
(iv) Injury or illness that requires intervention to prevent
permanent impairment of a body structure or function;
(3) Date of event;
(4) Date of report by the initial reporter;
(5) Description of the event or problem to include a discussion of
how the device was involved, nature of the problem, patient followup or
required treatment, and any environmental conditions that may have
influenced the event;
(6) Description of relevant tests, including dates and laboratory
data; and
(7) Other relevant patient history including preexisting medical
conditions.
(c) Device information (Block D) shall contain the following:
(1) Brand name;
(2) Type of device;
(3) Manufacturer name and address;
(4) Operator of the device (health professional, patient, lay user,
other);
(5) Expiration date;
(6) Model number, catalog number, serial number, lot number or
other identifying number;
(7) Date of device implantation (month, day, year);
(8) Date of device explantation (month, day, year);
(9) Whether the device was available for evaluation, and whether
the device was returned to the manufacturer, and if so, the date it was
returned to the manufacturer; and
(10) Concomitant medical products and therapy dates. (Do not list
products that were used to treat the event.)
(d) Initial reporter information (Block E) shall contain the
following:
(1) Name, address, and phone number of the reporter who initially
provided information to the user facility, manufacturer, or
distributor;
(2) Whether the initial reporter is a health professional;
(3) Occupation; and
(4) Whether the initial reporter also sent a copy of the report to
FDA, if known.
(e) Importer information (Block F) shall contain the following:
(1) Whether reporter is an importer;
(2) Importer report number;
(3) Importer address;
(4) Contact person;
(5) Contact person's telephone number;
(6) Date the importer became aware of the event (month, day, year);
(7) Type of report (initial or followup (if followup, include
report number of initial report));
(8) Date of the importer report (month, day, year);
(9) Approximate age of device;
(10) Event problem codes--patient code and device code (refer to
FDA ``Coding Manual For Form 3500A'');
(11) Whether a report was sent to FDA and the date it was sent
(month, day, year);
(12) Location, where event occurred;
(13) Whether a report was sent to the manufacturer and the date it
was sent (month, day, year); and
(14) Manufacturer name and address; if available.
Sec. 803.57 [Removed]
15. Section 803.57 Annual certification is removed.
PART 804--MEDICAL DEVICE DISTRIBUTOR REPORTING
16. Part 804 is removed.
[[Page 4121]]
Dated: August 6, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-1785 Filed 1-25-00; 8:45 am]
BILLING CODE 4160-01-F